510(k) · Cleared
ClearedSpacelabs Medical Clinical Event Interface, Model 91847
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spacelabs Medical, Inc. · MSX System, Network And Communication, Physiological Monitors
Cleared on Sep 19, 2006 as substantially equivalent to K992749 (Spacelabs Medical, Inc., 2000) after a 43-day review. Its family tree reaches back 4 generations to 1997. 21 later devices descend from it.
- Decided
- Sep 19, 2006
- Review
- 43 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K962827 (1997). 5 ancestors in all, the oldest K945277 (1995). 21 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK962827 Alarm Display Unit/Pager-Lan System (Adu)Marquette Electronics, Inc. · 1997
- 3 generations backK971868 Impact (Informing Mobile Personnel and Care Tracking) Pager SystemMarquette Electronics, Inc. · 1997
- 2 generations backK973527 Cardio-Pager SystemData Critical Corp. · 1998
- 1 generation backK992749 Ultraview Waveform Pager System, Model 91841Spacelabs Medical, Inc. · 2000
- This deviceK062278 Spacelabs Medical Clinical Event Interface, Model 91847Spacelabs Medical, Inc. · 2006
- Descendant · cites it directly · 14 of its ownK103634 Ascom Clinicalconnex CardiomaxAscom (Us), Inc. · 2011
- Descendant · 2 generations on · 5 of its ownK130339 Clinical Alert NotificationExtension, Inc. · 2013
- Descendant · cites it directly · 5 of its ownK102974 Intellisphere Event Managment System Rel. 10.00Philips Medical Systems · 2011
- Descendant · 3 generations on · 4 of its ownK152341 ViSi Mobile Monitoring SystemSotera Wireless, Inc. · 2015
- Descendant · 2 generations on · 3 of its ownK111215 Ascom Mobile Monitoring Gateway (MMG)Ascom (Sweden) AB · 2011 · Recalled
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K103634Ascom Clinicalconnex CardiomaxAscom (Us), Inc. · 2011 · cites it directly14descendants
- K130339Clinical Alert NotificationExtension, Inc. · 2013 · 2 generations on5descendants
- K102974Intellisphere Event Managment System Rel. 10.00Philips Medical Systems · 2011 · cites it directly5descendants
- K152341ViSi Mobile Monitoring SystemSotera Wireless, Inc. · 2015 · 3 generations on4descendants
- K111215Ascom Mobile Monitoring Gateway (MMG)Ascom (Sweden) AB · 2011 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962827 | Alarm Display Unit/Pager-Lan System (Adu) | Marquette Electronics, Inc. | 1997 | — |
| −3 | K971868 | Impact (Informing Mobile Personnel and Care Tracking) Pager System | Marquette Electronics, Inc. | 1997 | — |
| −2 | K973527 | Cardio-Pager System | Data Critical Corp. | 1998 | — |
| −1 | K992749 | Ultraview Waveform Pager System, Model 91841 | Spacelabs Medical, Inc. | 2000 | — |
| 0 (this device) | K062278 | Spacelabs Medical Clinical Event Interface, Model 91847 | Spacelabs Medical, Inc. | 2006 | — |
| +1 | K103634 | Ascom Clinicalconnex Cardiomax | Ascom (Us), Inc. | 2011 | — |
| +2 | K130339 | Clinical Alert Notification | Extension, Inc. | 2013 | — |
| +1 | K102974 | Intellisphere Event Managment System Rel. 10.00 | Philips Medical Systems | 2011 | — |
| +3 | K152341 | ViSi Mobile Monitoring System | Sotera Wireless, Inc. | 2015 | — |
| +2 | K111215 | Ascom Mobile Monitoring Gateway (MMG) | Ascom (Sweden) AB | 2011 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 4 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MSX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MSX device
- #1 K242750 Central Stationscore 21.5 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992749 | Ultraview Waveform Pager System, Model 91841Summary page 3…itor. Test The Spacelabs Medical Clinical Event Interface (CEI), Model 91847 and Discussion: the Spacelabs Medical Clinical Messenger, model 91841, K992749 are substantially equivalent in design concepts, technologies and materials. CEI was validated… | 2000 |
What descends from it? (21)
See all 212 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K103634 (Ascom (Us), Inc., 2011) has gone furthest, with 14 descendants of its own.
- 1 other device also cites its predicate K992749.
How does its category compare?
All MSX devicesMSX System, Network And Communication, Physiological Monitors: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSX
295in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSX
19in 2025
MAUDE reports naming product code MSX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 58 | 1 | 5 |
| 2008 | 1 | — | 1 | 6 |
| 2009 | 1 | — | 2 | 7 |
| 2010 | 3 | 43 | 1 | 14 |
| 2011 | 7 | 72 | 1 | 3 |
| 2012 | 4 | 145 | 2 | 4 |
| 2013 | 2 | — | 0 | 17 |
| 2014 | 3 | 165 | 0 | 32 |
| 2015 | 5 | 138 | 2 | 31 |
| 2016 | 3 | 174 | 0 | 11 |
| 2017 | 2 | — | 2 | 16 |
| 2018 | 4 | 111 | 1 | 15 |
| 2019 | 4 | 92 | 0 | 15 |
| 2020 | 5 | 193 | 0 | 25 |
| 2021 | 3 | 227 | 0 | 17 |
| 2022 | 5 | 177 | 1 | 18 |
| 2023 | 3 | 244 | 0 | 10 |
| 2024 | 4 | 212 | 0 | 32 |
| 2025 | 4 | 295 | 1 | 19 |
| 2026 | 5 | 145 | 2 | — |
What is it indicated for?
The intended use of the Spacelabs Medical Clinical Event Interface is to interface with tile Spacelabs monitoring network in order to provide a secondary means of annunciating and displaying patient alarm infornation to mdbile healthcare providers. The device is indicated for use in real-time monitoring of routine patient status and alarm events. The pager is intended to serve as a parallel, redundant mechanism to inform the clinical staff of patient…
Read the full statement (195 words)
The intended use of the Spacelabs Medical Clinical Event Interface is to interface with tile Spacelabs monitoring network in order to provide a secondary means of annunciating and displaying patient alarm infornation to mdbile healthcare providers. The device is indicated for use in real-time monitoring of routine patient status and alarm events. The pager is intended to serve as a parallel, redundant mechanism to inform the clinical staff of patient events. The Clinical Event Interface System is intended for use as a secondary alarm in any hospital environment currently using or intending to use a Spacelabs patient monitoring network. The Clinical Event Interface supplements the primary patient-monitoring system by providing a forwarding mechanism for annunciating and displaying patient alarm events and the critical information associated with the events - including parameter values and waveforms, typically within 4 - 8 seconds of an alarm event on the patient monitor. The pager provides an audio or vibrating alert along with a series of displays showing patient identification, alarm parameters, and up to a 12-second waveform snapshot.
The Spacelabs Medical Clinical Event Interface is a secondary alarm. It does not replace the primary alarm function on the monitor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062278 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062278: Spacelabs Medical Clinical Event Interface, Model 91847.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062278
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026